Daily corticosteroids to prevent infection associated relapses in patients with frequently relapsing nephrotic syndrome
- Registration Number
- CTRI/2008/091/000245
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Patients with idiopathic, steroid responsive nephrotic syndrome, 1 to 16 years' old, having frequent relapses or steroid dependence shall be studied. Only patients with a minimum follow up of 9 months at this center will be included. Standard definitions will be used for defining the course of nephrotic syndrome
1.Patients with impaired renal functions (serum creatinine > 1.2 mg/dl or urea > 45 mg/dl, confirmed once over a period of 2 weeks).
2.Patients with initial or late steroid resistance.
3.Patients who have received immunosuppressive medications, other than oral prednisolone, in the preceding 6 months.
4.Patients who require prednisolone at dose exceeding 1 mg/kg on alternate days for maintaining remission.
5.Patients with features of steroid toxicity (obesity, cataract, hypertension) (Table 1).
6.Patients staying more than 100 km from the Institute or those who not willing to come for clinic visits every two months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse rates (episodes/patient per year) will be compared in both groups, in the six months prior and during one-year follow up.Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method cumulative dose of prednisolone administered (mg/kg per day) will be compared 6-months prior and during the period of the study in the two groups. The frequencies of intercurrent infections shall be determined.Timepoint: 12 months